Study slams asthma drugs

Long-lasting medicines found to increase risk of death.

Long-lasting medicines found to increase risk of death.

June 06, 2006|MARC KAUFMAN The Washington Post

WASHINGTON -- Popular and long-acting asthma medicines such as Advair and Serevent pose a substantially increased risk of hospitalization and death to users compared with placebos, according to a new analysis of 19 studies on the subject. The analysis also found that the increased risks of the long-acting bronchodilators affect a broad range of users -- more than doubling the rate at which asthma patients had to be hospitalized. Most experts have believed that the powerful bronchodilators are harmful only to a small number of people genetically predisposed to having a negative reaction. "What we have here is a drug that increases the number of people who will die from the disease it is treating," said lead author Shelley Salpeter of Stanford University. "The long-acting bronchodilators can help reduce symptoms for many people, but we think the price in terms of serious side effects and deaths is unacceptable." The Food and Drug Administration has voiced concerns about the widely used medicines, and last fall it required drug makers to prepare stiff new warnings to the package label. But the new analysis, published in the journal Annals of Internal Medicine, raises the possibility that the drug should be taken off the market if it continues to be so widely used. "The use of long-acting (bronchodilators) could be associated with a clinically significant number of unnecessary hospitalizations, intensive care unit admissions and deaths each year," the authors wrote. "Black-box warnings on the labeling for these agents clearly outline the increased risk for asthma-related deaths associated with their use, but these warnings have not changed prescribing practices of physicians." One of the long-lasting bronchodilators is Advair Diskus, made by GlaxoSmithKline. It brought in $3.4 billion last year for the company, making it the nation's fifth biggest-selling drug, according to IMS Health, which tracks health data. More than 3.5 million patients use the drug. In the new analysis, the authors estimated Advair "may be responsible" for as many as 4,000 of the 5,000 asthma-related deaths each year in the United States. Glaxo spokeswoman Mary Anne Rhyne disputed that figure and said the Centers for Disease Control and Prevention has found a decline in asthma-related deaths since the long-acting bronchodilators came on the market in the mid-1990s. Rhyne said Advair has been recommended for use in treatment guidelines for asthma from the National Institutes for Health because it reduces symptoms and allows asthma sufferers to sleep through the night, exercise and generally resume normal lives.